Ohio Admin. Code 4723-9-10 - Formulary; standards of prescribing for advanced practice registered nurses designated as clinical nurse specialists, certified nurse-midwives, or certified nurse practitioners
(A) Definitions; for purposes of this rule
and interpretation of the formulary set forth in paragraph (B) of this rule,
except as otherwise provided:
(1) "Acute
pain" means pain that normally fades with healing, is related to tissue damage,
significantly alters a patient's typical function, and is expected to be
time-limited and not more than six weeks in duration.
(2) "Chronic pain" means pain that has
persisted after reasonable medical efforts have been made to relieve it and
continues either episodically or continuously for twelve or more weeks
following initial onset of pain. It may be the result of an underlying medical
disease or condition, injury, medical treatment, inflammation, or unknown
cause. "Chronic pain" does not include pain associated with a terminal
condition or with a progressive disease that, in the normal course of
progression, may reasonably be expected to result in a terminal
condition.
(3) "Extended-release or
long-acting opioid analgesic" means an opioid analgesic that:
(a) Has United States food and drug
administration approved labeling indicating that it is an extended-release or
controlled release formulation;
(b)
Is administered via a transdermal route; or
(c) Contains methadone.
(4) "Family member" means a spouse, parent,
child, sibling or other individual with respect to whom an advanced practice
registered nurse's personal or emotional involvement may render the advanced
practice registered nurse unable to exercise detached professional judgment in
reaching diagnostic or therapeutic decisions.
(5) "Hospice care program" has the same
meaning as in section
3712.01 of the Revised
Code.
(6) "ICD-10-CM medical
diagnosis code" means the disease code in the most current international
classification of diseases, clinical modifications published by the United
States department of health and human services.
(7) "Opioid analgesic" has the same meaning
as in section 3719.01 of the Revised Code, and
means a controlled substance that has analgesic pharmacological activity at the
opioid receptors of the central nervous system, including but not limited to
the following drugs and their varying salt forms or chemical congeners:
buprenorphine, butorphanol, codeine (including acetaminophen and other
combination products), dihydrocodeine, fentanyl, hydrocodone (including
acetaminophen combination products), hydromorphone, meperidine, methadone,
morphine sulfate, oxycodone (including acetaminophen, aspirin, and other
combination products), oxymorphone, tapentadol, and tramadol.
(8) "Medication therapy management" has the
same meaning as in rules adopted by agency 4729 of the Administrative
Code.
(9) "Minor" has the same
meaning as in section
3719.061 of the Revised
Code.
(10) "Morphine equivalent
daily dose (MED)" means a conversion of various opioid analgesics to a morphine
equivalent dose by the use of accepted conversion tables provided by the state
board of pharmacy at: https://www.ohiopmp.gov/MED_Calculator.aspx
(effective 2017).
(11) "Palliative
care" has the same meaning as in section
3712.01 of the Revised
Code.
(12) "Sub-acute pain" means
pain that has persisted after reasonable medical efforts have been made to
relieve it and continues either episodically or continuously for more than six
weeks but less than twelve weeks following initial onset of pain. It may be the
result of an underlying medical disease or condition, injury, medical or
surgical treatment, inflammation, or unknown cause.
(13) "Terminal condition" has the same
meaning as in section
2133.01 of the Revised
Code.
(B) Exclusionary
formulary. An advanced practice registered nurse with a current valid license
issued by the board and designated as a certified nurse practitioner, clinical
nurse specialist or certified nurse midwife shall not prescribe or furnish any
drug or device in violation of federal or Ohio law, or rules adopted by the
board, including this rule. The prescriptive authority of an advanced practice
registered nurse designated as a certified nurse practitioner, clinical nurse
specialist and certified nurse midwife shall not exceed the prescriptive
authority of the collaborating physician or podiatrist.
(C) The committee on prescriptive
governance shall review the exclusionary formulary at least twice a year, and
submit the recommended exclusionary formulary to the board. After reviewing a
formulary submitted by the committee, the board may either adopt the formulary
as a rule or ask the committee to reconsider and resubmit the
formulary.
The board shall not adopt any rule
that does not conform to a formulary developed by the
committee.
(1)
The ability to prescribe the drug or therapeutic device is within the scope of
practice in the advanced practice registered nurse's license
designation;
(2) The prescription
is consistent with the terms of a standard care arrangement entered into with a
collaborating physician;
(3) The
prescription would not exceed the prescriptive authority of the collaborating
physician, including restrictions imposed on the physician's practice by action
of the United States drug enforcement administration or the state medical
board, or by the state medical board rules, including but not limited to rule
4731-11-09 of the Administrative
Code;
(4) The individual drug or
subtype or therapeutic device is not one excluded by the exclusionary formulary
set forth in paragraph (B) of this rule;
(5) The prescription meets the requirements
of state and federal law, including but not limited to this rule, and all
prescription issuance rules adopted by agency 4729 of the Administrative
Code;
(6) A valid
prescriber-patient relationship exists. This relationship may include, but is
not limited to:
(a) Obtaining a relevant
history of the patient;
(b)
Conducting a physical or mental examination of the patient;
(c) Rendering a diagnosis;
(d) Prescribing medication;
(e) Consulting with the collaborating
physician when necessary; and
(f)
Documenting these steps in the patient's medical records;
(7) Notwithstanding paragraph
(D)
(C)(6) of
this rule, a clinical nurse specialist, certified nurse-midwife, or certified
nurse practitioner may prescribe or personally furnish a drug according to
section 4723.4810 of the Revised Code to
not more than a total of two individuals who are sexual partners of the
advanced practice registered nurse's patient.
(8) If the patient is a family member,
acceptable and prevailing standards of safe nursing care require that the
advanced practice registered nurse maintain detached professional judgment. The
advanced practice registered nurse shall not prescribe to a family member
unless:
(a) The advanced practice registered
nurse is able to exercise detached professional judgment in reaching diagnostic
or therapeutic decisions;
(b) The
prescription is documented in the patient's record.
(9) Controlled substances. For drugs that are
a controlled substance:
(a) The advanced
practice registered nurse has obtained a United States drug enforcement
administration registration, except if not required to do so as provided in
rules adopted by agency 4729 of the Administrative Code, and indicates the
number on the prescription;
(b) The
prescription indicates the ICD-10-CM medical diagnosis code of the primary
disease or condition that the controlled substance is being used to treat. The
code shall, at minimum, include the first four alphanumeric characters of the
ICD-10 CM medical diagnosis code, sometimes referred to as the category and
etiology (ex. M165);
(c) The
prescription indicates the days' supply of the controlled substance
prescription.
(d) The patient is
not a family member; and
(e) The
advanced practice registered nurse shall not self-prescribe a controlled
substance.
(1) A patient has a terminal
condition;
(2) A physician
initially prescribed the substance for the patient; and
(3) The prescription is for a quantity that
does not exceed the amount necessary for the patient's use in a single,
seventy-two hour period.
(1) A hospital
registered under section
3701.07 of the Revised
Code;
(2) An entity owned or
controlled, in whole or in part, by a hospital or by an entity that owns or
controls, in whole or in part, one or more hospitals;
(3) A health care facility operated by the
department of mental health or the department of developmental
disabilities;
(4) A nursing home
licensed under section
3721.02 of the Revised Code or
by a political subdivision certified under section
3721.09 of the Revised
Code;
(5) A county home or district
home operated under Chapter 5155. of the Revised Code that is certified under
the medicare or medicaid program;
(6) A hospice care program;
(7) A community mental health agency, as
defined in section 5122.01 of the Revised
Code;
(8) An ambulatory surgical
facility, as defined in section
3702.30 of the Revised
Code;
(9) A freestanding birthing
center, as defined in section
3702.141 of the Revised
Code;
(10) A federally qualified
health center, as defined in section
3701.047 of the Revised
Code;
(11) A federally qualified
health center look-alike, as defined in section
3701.047 of the Revised
Code;
(12) A health care office or
facility operated by the board of health of a city or general health district
or the authority having the duties of a board of health under section
3709.05 of the Revised
Code;
(13) A site where a medical
practice is operated, but only if the practice is comprised of one or more
physicians who also are owners of the practice; the practice is organized to
provide direct patient care; and the clinical nurse specialist, certified
nurse-midwife, or certified nurse practitioner providing services at the site
has a standard care arrangement and collaborates with at least one of the
physician owners who practices primarily at that site; or
(14) A residential care facility, as defined
in section 3721.01 of the Revised
Code.
(1)
Extended-release or long-acting opioid analgesics shall not be prescribed for
the treatment of acute pain;
(2)
Before prescribing an opioid analgesic, the advanced practice registered nurse
shall first consider non-opioid treatment options. If opioid analgesic
medications are required as determined by history and physical examination, the
prescription should be for the minimum quantity and potency needed to treat the
expected duration of pain, with a presumption that a three-day supply or less
is frequently sufficient;
(3) In
all circumstances where opioid analgesics are prescribed for acute pain:
(a) Except as provided in paragraph
(H)
(G)(3)(a)(iii) of this rule, the duration of the first
opioid analgesic prescription for the treatment of an episode of acute pain
shall be:
(i) For adults, not more than a
seven-day supply with no refills;
(ii) For minors, not more than a five-day
supply with no refills. As set forth in section
4723.481 of the Revised Code,
the advanced practice registered nurse shall comply with section
3719.061 of the Revised Code,
including but not limited to obtaining the parent or guardian's written consent
prior to prescribing an opioid analgesic to a minor;
(iii) The seven-day limit for adults and
five-day limit for minors may be exceeded for pain that is expected to persist
for longer than seven days based on the pathology causing the pain. In this
circumstance, the reason that the limits are being exceeded and the reason that
a non-opioid analgesic medication was not appropriate to treat the patient's
condition shall be documented in the patient's medical record; and
(iv) If a patient is intolerant of or
allergic to an opioid medication initially prescribed, a prescription for a
different opioid medication may be issued at any time during the initial
seven-day or five-day dosing period, and the new prescription shall be subject
to the requirements of this rule. The patient's intolerance or allergy shall be
documented in the patient's medical record, and the patient advised to safely
dispose of the unused medication;
(b) The patient, or a minor's parent or
guardian, shall be advised of the benefits and risks of the opioid analgesic,
including the potential for addiction, and the advice shall be documented in
the patient's medical record; and
(c) The total morphine equivalent dose (MED)
of a prescription for opioid analgesics for treatment of acute pain shall not
exceed an average of thirty MED per day, except when:
(i) The circumstances set forth in paragraph
(A)(3)(c) of rule
4731-11-13 of the Administrative
Code exist; and
(ii) The patient's
treating physician has entered a standard care arrangement with the advanced
practice registered nurse that states the understanding of the physician as to
when the advanced practice registered nurse may exceed the thirty MED average,
and when the advanced practice registered nurse must consult with the physician
prior to exceeding the thirty MED average. The standard care arrangement in
this circumstance must comply with rule
4731-11-13 of the Administrative
Code, and the advanced practice registered nurse must document in the patient's
record the reason for exceeding the thirty MED average and the reason it is the
lowest dose consistent with the patient's medical
condition.
(1) To a patient in a hospice care;
(2) To a patient who is receiving palliative
care;
(3) To a patient who has been
diagnosed with a terminal condition, as defined as follows:
(a) An irreversible, incurable, and
untreatable condition caused by disease, illness, or injury from which, to a
reasonable degree of medical certainty as determined in accordance with
reasonable medical standards by a physician who has examined the patient, both
of the following apply:
(i) There can be no
recovery; and
(ii) Death is likely
to occur within a relatively short time if life-sustaining treatment is not
administered; or
(4) To a patient who has cancer or a
condition associated with the individual's cancer or history of
cancer.
(1) Prescriptions for opioid analgesics for
the treatment of opioid addiction utilizing a controlled substance that is
approved by the FDA for opioid detoxification or maintenance treatment;
or
(2) Inpatient prescriptions as
defined in rules adopted by agency 4729 of the Administrative Code.
(1) Prior to treating, or continuing to
treat sub-acute or chronic pain with an opioid analgesic, the advanced practice
registered nurse shall first consider and document non-medication options. If
opioid analgesic medications are required as determined by a history and
physical examination, the advanced practice registered nurse shall prescribe
the minimum quantity and potency needed to treat the expected duration of pain
and improve the patient's ability to function;
(2) Before prescribing an opioid analgesic
for sub-acute or chronic pain, the advanced practice registered nurse shall
complete or update and document in the patient record assessment activities to
assure the appropriateness and safety of the medication, as required by rule
4731-11-14 of the Administrative
Code, including but not limited to:
(a)
Completing an OARRS check in compliance with rule
4723-9-12 of the Administrative
Code;
(b) Offering the patient a
prescription for naloxone if the following circumstances exist:
(i) The patient has a prior history of opioid
overdose;
(ii) The patient is
co-prescribed a benzodiazepine, sedative hypnotic drug, carisprodal, tramadol,
or gabapentin;
(iii) The patient
has a concurrent substance use disorder; or
(iv) The dosage exceeds eighty MED as
discussed in paragraph (K)
(J)(5) of this rule;
(c) The advanced practice registered nurse
shall consider offering the patient a prescription for naloxone if the dosage
exceeds fifty MED as discussed in paragraph (K)
(J)(4) of this
rule.
(3) During the
course of treatment with an opioid analgesic at doses below the average of
fifty MED per day, the advanced practice registered nurse shall provide
periodic follow-up assessment and documentation of the patient's functional
status, the patient's progress toward treatment objectives, indicators of
possible addiction, drug abuse or diversion, and any adverse drug
effects.
(4) Fifty MED. Prior to
increasing the opioid dosage to a daily average of fifty MED or greater, the
advanced practice registered nurse shall complete and document in the patient
record the activities and information set forth in rule
4731-11-14 of the Administrative
Code, including but not limited to the following:
(a) Review and update the assessment
completed in paragraph (K)
(J)(2) of this rule if needed. The advanced practice
registered nurse may rely on an appropriate assessment completed within a
reasonable time if the advanced practice registered nurse is satisfied that he
or she may rely on that information for purposes of meeting the requirements of
Chapter 4723-8 and Chapter 4723-9 of the Administrative Code;
(b) Except when the patient was prescribed an
average daily dosage that exceeded fifty MED before the effective date of this
rule, document consideration of:
(i)
Consultation with a specialist in the area of the body affected by the
pain;
(ii) Consultation with a pain
management specialist;
(iii)
Obtaining a medication therapy management review by a pharmacist;
(iv) Consultation with a specialist in
addiction medicine or addiction psychiatry, if aberrant behaviors indicating
medication misuse or substance use disorder are noted;
(c) The advanced practice registered nurse
shall consider offering the patient a prescription for naloxone if the dosage
exceeds fifty MED as discussed in paragraph (K)
(J)(4) of this
rule;
(d) During the course of
treatment with an opioid analgesic at doses at or above the average of fifty
MED per day, the advanced practice registered nurse shall complete and document
in the patient record all of the information and activities required by rule
4731-11-14 of the Administrative
Code not less than every three months.
(5) Eighty MED. Prior to increasing the
opioid dosage to a daily average of eighty MED or greater, the advanced
practice registered nurse shall complete and document in the patient record the
activities and information set forth in rule
4731-11-14 of the Administrative
Code, including but not limited to the following:
(a) A written pain management agreement shall
be entered with the patient that outlines the advanced practice registered
nurse's and patient's responsibilities during treatment, which requires the
patient or patient guardian's agreement to all of the provisions set forth in
rule 4731-11-14 of the Administrative
Code;
(b) The advanced practice
registered nurse shall offer the patient a prescription for naloxone;
(c) Except when the patient was prescribed an
average daily dosage that exceeded eighty MED before the effective date of this
rule, the advanced practice registered nurse shall obtain at least one of the
following based upon the patient's clinical presentation:
(i) Consultation with a specialist in the
area of the body affected by the pain;
(ii) Consultation with a pain management
specialist;
(iii) A medication
therapy management review by a pharmacist; or
(iv) Consultation with a specialist in
addiction medicine or addiction psychiatry, if aberrant behaviors indicating
medication misuse or substance use disorder are noted.
(6) One hundred twenty MED. The
advanced practice registered nurse shall not prescribe a dosage that exceeds an
average of one hundred twenty MED per day. This prohibition shall not apply
under the following circumstances:
(a) The
advanced practice registered nurse holds national certification by a national
certifying organization approved according to section
4723.46 of the Revised Code in:
(i) Pain management;
(ii) Hospice and palliative care;
(iii) Oncology; or
(iv) Hematology, or coursework in hematology
leading to certification in oncology;
(b) The advanced practice registered nurse
of has received a written recommendation for a
dosage exceeding an average of one hundred twenty MED per day from a board
certified pain medicine physician, a board certified hospice and palliative
care physician, or a board certified oncology or hematology physician, who
based the recommendation on a face-to-face visit and examination of the
patient. The advanced practice registered nurse shall maintain the written
recommendation in the patient's record; or
(c) The patient was receiving an average
daily dose of one hundred twenty MED or more prior to the effective date of
this rule. However, prior to escalating the patient's dose, the advanced
practice registered nurse shall receive a written recommendation as set forth
in paragraph (K)
(J)(6)(b) of this rule.
(7) The requirements of paragraph
(K)
(J) of
this rule do not apply when an opioid analgesic is prescribed:
(a) To a patient in hospice care;
(b) To an patient who has terminal cancer or
another terminal condition, as defined as follows:
An irreversible, incurable, and untreatable condition caused by disease, illness, or injury from which, to a reasonable degree of medical certainty as determined in accordance with reasonable medical standards by a physician who has examined the patient, both of the following apply:
(i) There can be no recovery; and
(ii) Death is likely to occur within a
relatively short time if life-sustaining treatment is not administered;
or
(c) As an inpatient
prescription as defined in rules adopted by agency 4729 of the Administrative
Code.
(L) Drugs approved by the FDA but
not yet reviewed and approved by the committee on prescriptive governance may
be prescribed, unless later disapproved by the committee on prescriptive
governance, if:
(1) The drug type or subtype is not
excluded on the formulary set forth in paragraph (B) of this rule;
and
(2) The collaborating physician has
agreed in the standard care arrangement that the advanced practice registered
nurse may prescribe drugs approved by the FDA, that meet the criteria set forth
in paragraphs (L)(1) and (L)(2) of this rule, that have not yet been reviewed
and approved by the committee on prescriptive governance.
Notes
Promulgated Under: 119.03
Statutory Authority: 4723.50, 4723.07, 3719.062
Rule Amplifies: 4723.481, 4723.492, 4723.491, 4723.49, 4723.488, 4723.487, 4723.486
Prior Effective Dates: 02/01/2002, 02/01/2003, 02/01/2006, 04/01/2006, 02/01/2008, 02/01/2011, 02/01/2012, 11/05/2012, 02/01/2014, 02/01/2016, 08/31/2017, 01/01/2018, 12/22/2018, 02/01/2020, 02/01/2021
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